Clinical Trial News

A comprehensive analysis of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) reveals that lifestyle changes and metformin significantly reduce the risk of developing diabetes. Adherent participants to these interventions experienced a lower incidence of diabetes and accrued more quality-adjusted life-years (QALYs) compared to those on placebo. The study also highlights the cost-effectiveness of these interventions from a health system perspective, with lifestyle and metformin interventions being cost-saving relative to placebo.

Adding cetuximab to the FOLFIRI regimen significantly improves outcomes for metastatic colorectal cancer patients with KRAS wild-type, including overall survival, progression-free survival, and response rates.

Urovant Sciences announced FDA approval of GEMTESA® (vibegron) 75 mg tablets for overactive bladder (OAB) treatment, offering a new option for adults with symptoms like urge urinary incontinence, urgency, and frequency. GEMTESA, a beta-3 agonist, relaxes the bladder muscle, improving symptoms without known cognitive decline risks.

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

The FDA has released final guidance for assessing cardiovascular risks in new type 2 diabetes treatments, emphasizing the importance of clinical trials to ensure these therapies do not increase cardiovascular event risks. The guidance mandates detailed safety information from Phase II and III trials, including the establishment of a cardiovascular end-point committee and the inclusion of high-risk individuals. A meta-analysis of trial data is required post-trial to evaluate drug safety comprehensively.

A study on mifepristone's contraceptive effect found no pregnancies in 76 women over 456 women-months. The 50-mg group had fewer bleeding days and more no-bleeding days than the 25-mg group in later cycles. Side effects were mild and uncommon.

The Klempner et al. trials on chronic Lyme disease treatment's generalizability is questioned due to a select patient group, potentially limiting applicability to broader populations. The review highlights the trials' failure to address treatment delays and previous antibiotic courses, suggesting these factors may influence outcomes.

The FDA approved the first completely implantable artificial heart, AbioCor, for patients with severe heart issues unsuitable for transplants. It's restricted to 4,000 units annually, targeting end-stage patients. The device extends life by an average of 4.5 months, with some living up to 17 months. It's a 2-pound mechanical heart, requiring patients to be at least 6 feet tall and 170 pounds. Costing around $250,000, its insurance coverage is unclear. The approval aims to encourage further technological refinement.

A trial on 55 PLS patients found IV ceftriaxone improved fatigue but not cognitive function or infection markers. Adverse events occurred, suggesting caution with additional antibiotic therapy for PLS fatigue.

The FDA has approved the MED-EL Cochlear Implant System for a broader range of patients, including adults with bilateral moderate to profound sensorineural hearing loss who benefit minimally from hearing aids.